CE Marking

Tens of thousands of medical devices reflect the wide range of medical technology. These products are generally divided into two groups: active medical devices and non-active medical devices.

The distinguishing criteria can be found in the classification rules Medical Device Directive 93/42/EEC about medical devices. MEDCERT is accredited for the examination and certification of almost all medical devices, except for a few large medical devices. MEDCERT offers you professional know-how and experience as a basis for evaluation and certification of medical devices – even of highly complex and innovative equipment. According to the classification rules, the medical devices are classified into four risk classes: I, IIa, IIb und III (depending on the risk in the application).

Further to this, there are subclasses Is (for sterile class I products) and Im (class I products with a measuring function). The rules of classification are defined in Annex IX of the Medical Device Directive 93/42/EEC. The application of classification rules depends on the intended use of the products and therefore the manufacturer bears the whole responsibility for this.

Some of the examples are presented in our risk classes.